Guided Care: Integrating High Tech and High Touch
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Purpose
The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of the health and well-being of the frail elderly. A specially trained registered nurse will work closely with 1-3 primary care physicians to provide the most complex older patients (and their unpaid caregivers) with health care that is comprehensive, coordinated, patient-centered, and proactive. The study will evaluate the effects of Guided Care on:
- older persons' physical and mental health, health services utilization, quality of care, self-efficacy, and satisfaction with care;
- older persons' unpaid caregivers' burden; and
- primary care physicians' satisfaction with their care of chronically ill patients.
| Condition | Intervention |
|---|---|
|
Chronic Disease |
Behavioral: Guided Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Guided Care: Integrating High Tech and High Touch |
- SF-36 Physical Health Summary Scale [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
- SF-36 Mental Health Summary Scale [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
- Health Services Utilization [ Time Frame: Baseline, 8, 20, and 32 months ] [ Designated as safety issue: No ]Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data
- Perceived Quality of Care [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)
- Patient Satisfaction with Care [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
- Physician Satisfaction with Care [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
- Caregiver Burden [ Time Frame: Baseline, 6, and 18 months ] [ Designated as safety issue: No ]Using Modified Caregiver Strain Index
- Self-rated Health [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
| Enrollment: | 904 |
| Study Start Date: | February 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Guided Care |
Behavioral: Guided Care
Specially trained registered nurse (Guided Care Nurse) based in a primary care practice collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; "best practices" for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources.
|
| No Intervention: Usual Care |
Detailed Description:
Health care for older Americans with chronic conditions is often fragmented and provider-centric. In response, a team of investigators at Johns Hopkins University has translated the scientific principles of seven successful innovations into one patient-centered system of care. Supported by evidence-based guidelines and state-of-the-art information technology, "Guided Care" is undergoing a 12-month pilot test in older primary care patients with complex needs. A specially trained Guided Care nurse (GCN), based in a primary care practice, collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; "best practices" for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources.
The proposed multi-site study will measure the effects of Guided Care on the quality and outcomes of care for high-risk older persons, their unpaid caregivers, and their primary care physicians. The panels of 53 physicians in 7 practices will be screened to identify 1350 high-risk older patients. After about 850 have given informed consent and baseline interviews, clusters of 2-5 physicians at each practice site will be randomized to provide either Guided Care or usual care to their consenting patients. Each physician cluster in the Guided Care group will incorporate a GCN into its practice; the physician clusters in the control group will not.
Interviews and queries of administrative databases will provide evaluative data at baseline and at 12-, 24-, and 32-month follow-up intervals. The primary outcome variables are the participants' physical health and mental health (SF-36 Summary Scales) and health services utilization. Secondary outcome variables include: the quality of care; unpaid caregivers' burden; self-rated health; patient satisfaction; and primary care physicians' satisfaction. Intention-to-treat analyses will have 85% power (range of 70-97%) to detect clinically meaningful differences between the two groups.
The study is designed to facilitate the prompt dissemination of Guided Care, if the results of the trial are favorable. A stakeholders' advisory board, representing consumers, providers, delivery systems, insurers, regulators and policy-makers, will inform the operation and evaluation of the study - and it will facilitate the subsequent dissemination of its tools and technology throughout American health care.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Over 65
- Insured by KPMAG, USFHP/TRICARE, or Medicare FFS
- High likelihood of use of services in the coming year based on predictive modeling using current year's health care expenses
Exclusion Criteria:
- Moving out of area
- Currently assigned to case manager/in case management program
- Cognitive impairment and no legal representative
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University Bloomberg School of Public Health | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Charles Boult, MD, MPH, MBA | Johns Hopkins Bloomberg School of Public Health |
More Information
Additional Information:
No publications provided by Johns Hopkins Bloomberg School of Public Health
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Charles Boult, Professor, Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00121940 History of Changes |
| Other Study ID Numbers: | RO1 HS014580-01A1, HS014580, 5R03HS018256 |
| Study First Received: | July 18, 2005 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
|
Chronic Disease Nurses Caregivers Support Groups |
Additional relevant MeSH terms:
|
Chronic Disease Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013